Clinical Trial Manager II - Home Based (Poland)

About the role

Syneos Health is hiring a Clinical Trial Manager II for a home-based position in Poland. The role covers site management, clinical monitoring and central monitoring, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. It sits in the Clinical Trial Management job family, which oversees Phase 1 through Phase 4 studies.

Key responsibilities

• Oversee site interactions from post-activation through closeout, including patient recruitment and investigator payments
• Review study scope, budget and protocol, and escalate risks to the project manager
• Identify risks to deliverables, propose mitigations and present at key meetings such as the Kick Off Meeting
• Coordinate with Study Start Up, Patient Recruitment and Data Management to meet site activation, enrollment and database lock targets
• Maintain clinical study tools and templates, including the Clinical Monitoring Plan, and set up CTMS, dashboards and UAT
• Train the study team on protocol, CRFs, dashboards, SOPs and timelines
• Oversee CRAs and Central Monitors, resourcing, site assignments and corrective actions
• Review monitoring documentation and project dashboards (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS)
• Support inspection readiness and provide status updates to the client and leadership
• Provide feedback to line managers on staff performance and may mentor other CTMs

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Demonstrated ability to lead and align teams toward project milestones
• Experience in an international environment and expertise in site management and monitoring (clinical or central)
• Preferred experience with risk-based monitoring
• Understanding of clinical trial management financial principles and budget management
• Good computer skills and strong conflict resolution skills
• Modest travel may be required, approximately 20%

Required skills

• Knowledge of Good Clinical Practice (ICH GCP) and other applicable regulatory requirements
• Problem-solving and risk management approach to clinical research projects